ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WENT INTO COMMUNICATION LOSS WITH CONNECTED DEVICES AND WHEN THEY CHECKED OUT THE ORG, THEY SAW THAT IT HAS AN ERROR LIGHT LIT ON IT. NO PATIENT HARM WAS REPORTED. THEY WILL BE SENDING THIS ORG IN FOR AN EXCHANGE.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WENT INTO COMMUNICATION LOSS WITH CONNECTED DEVICES AND WHEN THEY CHECKED OUT THE ORG, THEY SAW THAT IT HAS AN ERROR LIGHT LIT ON IT. NO PATIENT HARM WAS REPORTED. THEY WILL BE SENDING THIS ORG IN FOR AN EXCHANGE. EVALUATION OF A SIMILAR DEVICE THAT WAS RETURNED FOR THE SAME REPORTED ISSUE OF ORG GOING INTO COMMUNICATION LOSS WAS TESTED BY NIHON KOHDEN REPAIR CENTER AND IT WAS FOUND THAT THE UNITS SOFTWARE WAS THE LIKELY CAUSE FOR THE REPORTED COMMUNICATION LOSS. NKRC REPLACED THE SOFTWARE IN THE UNIT WHICH WAS TESTED AND PASSED ALL FUNCTIONAL TESTS. INVESTIGATION SUMMARY: AN ERROR MESSAGE WOULD APPEAR ON THE DEVICE WHICH WOULD ALERT THE CLINICIANS TO THE ISSUE IN WHICH ALTERNATE MONITORING METHOD COULD BE PREPARED. AS LOGS WERE NOT RETRIEVED, ROOT CAUSE CANNOT BE DETERMINED. THE CAUSE OF THE ISSUE IS LIKELY TO BE RELATED TO THE SOFTWARE ON THE ORG. DUE TO THE LOW OCCURRENCE OF THE REPORTED ISSUE, IT IS UNLIKELY THAT THE CAUSE OF THE ISSUE IS RELATED TO THE DESIGN OF THE ORG SOFTWARE. THE SOFTWARE WAS POSSIBLY CORRUPTED DUE TO IMPROPER SHUTDOWNS OR POWER LOSS. LAST REPORTED COMPLAINT FOR ERROR LIGHT ON THE ORG WAS REPORTED ON 11/26/2021. FURTHER ACTION IS NOT WARRANTED. ATTEMPT # 1: 11/30/2021 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 12/21/2021 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: CUSTOMER REPLIED THAT THEY ARE NOT ABLE TO PROVIDE INFORMATION REQUESTED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WENT INTO COMMUNICATION LOSS WITH CONNECTED DEVICES AND WHEN THEY CHECKED OUT THE ORG, THEY SAW THAT IT HAS AN ERROR LIGHT LIT ON IT. NO PATIENT HARM WAS REPORTED. THEY WILL BE SENDING THIS ORG IN FOR AN EXCHANGE.

Additional Manufacturer Narrative

NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.